Dihydrogen [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']nickelate(2-)

Endpoint summary

Description of key information

Skin irritation:

No signs of dermal irritation were observed in the 26 volunteers treated with the test chemical as compared to the 21 of 26 volunteers treated with SDS. Hence the test chemical was considered to be not irritating to human skin and it can be classified under the category “Not Classified”.

Eye Irritation: 

No corneal opacity was observed in the rabbits at all observation times. Hence, the test chemical was considered to be not irritating to eyes. It can be classified under the category “Not Classified”.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from peer reviewed journals

Qualifier:

according to guideline

Guideline:

other: Human patch test

Principles of method if other than guideline:

Patch tests were performed oh human volunteers to assess the dermal irritation potential of the test chemical

GLP compliance:

not specified

Species:

other: humans

Strain:

not specified

Details on test animals or test system and environmental conditions:

no data available

Type of coverage:

occlusive

Preparation of test site:

other: intact skin

Vehicle:

water

Controls:

yes, concurrent positive control

Amount / concentration applied:

0.2 g solid moistened

Duration of treatment / exposure:

4 hours

Observation period:

24, 48 and 72 hours

Number of animals:

26

Details on study design:

TEST SITE
- Area of exposure: upper outer arm
- % coverage: 25 mm Plain Hill Top Chamber
- Type of wrap if used:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: after exposure

SCORING SYSTEM: Treatment sites were assessed for the presence of irritation using a four point scale.

Grading of response
0 - No reaction
+ - Weakly positive reaction (usually characterized by mild erythema or dryness across most of the treatment site)
++ - Moderately positive reaction (usually distinct erythema possibly spreading beyond the treatment site)
+ + + - Strongly positive reaction (strong, often spreading erythema with oedema)

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Interpretation of results:

other: not irritatng

Conclusions:

No signs of dermal irritation were observed in the 26 volunteers treated with the test chemical as compared to the 21 of 26 volunteers treated with SDS.
Hence the test chemical was considered to be not irritating to human skin and it can be classified under the category “Not Classified”.

Executive summary:

Patch tests were performed oh human volunteers to assess the dermal irritation potential of the test chemical. 0.2 g of the test chemical on a 25 mm Plain Hill Top Chambers containing a Webril pad (moistened for solid test materials) to the skin of the upper outer arm of 26 human volunteers for up to 4 hours. To avoid the production of unacceptably high reactions, test materials are applied progressively from 15 and 30 min through 1, 2, 3 and 4 hours.

Treatment sites are assessed for the presence of irritation using a four point scaleat 24, 48 and 72hours after patch removal. 0.2 ml of20% Sodium dodecycl sulphate was used as a positive control.

No signs of dermal irritation were observed in the 26 volunteers treated with the test chemical as compared to the 21 of 26 volunteers treated with SDS.

Hence the test chemical was considered to be not irritating to human skin and it can be classified under the category “Not Classified”.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from peer reviewed journals

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To assess the ocular irritation potential of the test chemical in rabbits according to Draize method

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

no data available

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

no data available

Duration of treatment / exposure:

single exposure

Observation period (in vivo):

From 1 hour till 21 days after instillation of test chemical

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

1

Details on study design:

SCORING SYSTEM: Draize method
Mean scores are calculated for each animal from gradings at 24, 48, and 72 h after instillation of the test chemical and these “severity scores” are then used to determine the classification of the test chemical

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No corneal opacity was observed in the rabbits at all observation times.

Table: Draize eye test reference database

Physical state	Purity	Commercial source	UN GHS category	Number of animals	Comments
Solid	≥99%	Sigma –Aldrich	NC	NO DATA	CO>0

Interpretation of results:

other: not irritating

Conclusions:

No corneal opacity was observed in the rabbits at all observation times. Hence, the test chemical was considered to be not irritating to eyes. It can be classified under the category “Not Classified”.

Executive summary:

An eye irritation study in rabbits was conducted to assess the irritation potential of the test chemical.The study was performed according to Draize method. Undiluted test chemical was instilled in the eyes of 1 rabbit and observed for signs of irritation till 7 days. The reactions observed were scored according to Draize method.Mean scores are calculated for each animal from gradings at 24, 48, and 72 h after instillation of the test chemical and these “severity scores” are then used to determine the classification of the test chemical.

No corneal opacity was observed in the rabbits at all observation times. Hence, the test chemical was considered to be not irritating to eyes. It can be classified under the category “Not Classified”.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation:

Study 1 :

Patch tests were performed oh human volunteers to assess the dermal irritation potential of the test chemical. 0.2 g of the test chemical on a 25 mm Plain Hill Top Chambers containing a Webril pad (moistened for solid test materials) to the skin of the upper outer arm of 26 human volunteers for up to 4 hours. To avoid the production of unacceptably high reactions, test materials are applied progressively from 15 and 30 min through 1, 2, 3 and 4 hours. Treatment sites are assessed for the presence of irritation using a four point scaleat 24, 48 and 72hours after patch removal. 0.2 ml of20% Sodium dodecycl sulphate was used as a positive control. No signs of dermal irritation were observed in the 26 volunteers treated with the test chemical as compared to the 21 of 26 volunteers treated with SDS.

Study 2 :

A Primary dermal irritation study was performed to assess the irritation potential of the test chemical in rabbits. The test chemical was applied as a 50% aqueous solution to the back skin of rabbits.The exposure time was 1, 5 and 15 minutes and 20 Hours on the back of the skin. Observation times 24 hours and 8 days after application. There were no irritation symptoms on the back skin at all observation times. Hence the test chemical was considered to be not irritating to skin.

Hence the test chemical was considered to be not irritating to human skin and it can be classified under the category “Not Classified”.

Eye Irritation:

Study 1 :

Based on the available studies for the closely related chemicals, the weight of evidence approach was applied to assess the ocular irritation potential of the nickel(II) EDTA complex. An eye irritation study in rabbits was conducted to assess the irritation potential of the test chemical. The study was performed according to the Draize method. An undiluted test chemical was instilled in the eyes of 1 rabbit and observed for signs of irritation till 7 days. The reactions observed were scored according to the Draize method. Mean scores are calculated for each animal from gradings at 24, 48, and 72 h after instillation of the test chemical and these “severity scores” are then used to determine the classification of the test chemical. No corneal opacity was observed in the rabbits at all observation times. Hence, the test chemical was considered to be not irritating to the eyes. It can be classified under the category “Not Classified”.

Study 2 :

A Primary ocular irritation study was performed to assess the ocular irritation potential of the test chemical in rabbits. The test chemical was instilled in rabbit eyes and observed for signs of irritation (duration, dose and observation not mentioned). The test chemical was not irritating to rabbit eyes in a primary eye irritation study.

Based on the available data for the test chemicals it can be concluded that the target chemical will also tend to behave in a similar manner to that of the read-across substances. Therefore, Nickel(II) EDTA complex was estimated to be not irritating to the eyes and it can be further classified under the category “Not Classified” as per CLP regulation.

Justification for classification or non-classification

The results of the experimental studies from the closely related substances indicate a possibility that Nickel(II) EDTA complex can be not irritating to skin and eyes.

Hence by applying the weight of evidence approach and using read across substances, Nickel(II) EDTA complex can be considered to be not irritating to skin and eyes. Thus as per CLP criteria, it was found to be  “Not Classified”.